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Insulin glargine U300 HOE901 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Insulin glargine U300 | EXPERIMENTAL | Once daily subcutaneous injection for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Insulin glargine U300 (new formulation of insulin glargine) HOE901 | DRUG | Pharmaceutical form:solution for injection Route of administration: subcutaneous |
Inclusion criteria: * Patients with T2DM inadequately controlled with non-insulin, non-injectable anti-hyperglycemic drug(s) and for whom the Investigator/treating physicians has decided that basal insulin is appropriate. * Signed written informed consent. Exclusion criteria: * Glycated hemoglobi...
Insulin glargine U300 HOE901 is an investigational long-acting insulin formulation developed by Sanofi for the treatment of type 2 diabetes mellitus. It is a new formulation of insulin glargine and is being studied in a Phase 3 clinical program. It is also known as insulin glargine U300.
Insulin glargine U300 HOE901 is being developed for the treatment of type 2 diabetes mellitus. Its clinical evaluation has focused on use in insulin-naive patients with T2DM, assessing the ease of use and safety of a new U300 pen injector device.
Insulin glargine U300 HOE901 targets the insulin receptor, or INSR, acting as an agonist. By binding and activating this receptor, it is designed to produce the glucose-lowering effects associated with insulin therapy in patients with type 2 diabetes mellitus.
Sanofi is the developer of insulin glargine U300 HOE901. Sanofi trades on the New York Stock Exchange under the ticker symbol SNY. The company is responsible for the clinical development program evaluating this new insulin glargine U300 formulation.
Insulin glargine U300 HOE901 is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 trial evaluating it has been completed, and no trials of this asset are currently active.
Insulin glargine U300 HOE901 has been studied in the Phase 3 trial NCT02227212, titled Ease of Use and Safety of the New U300 Pen Injector in Insulin-Naive Patients With T2DM. The completed trial enrolled 40 patients in Germany and included adults aged 18 years and older.